To attach the pole mounting bracket for the Breas Vivo 45 to use with a mobile stand (trolley), follow these steps:

1. Mount the bottom plate of the Vivo 45 to the trolley using two screws.
2. Ensure the ventilator is securely attached to the trolley with the mounting bracket.
3. Handle the trolley with care to avoid any risk when the ventilator is mounted.

This setup allows the ventilator to be mobile while providing treatment in an indoor, hospital environment.

This answer is automatically generated

Summary of Contents for Breas Vivo 45

Page 1 Breas Medical AB, Företagsvägen 1, SE-435 33 Mölnlycke, Sweden Phone +46 31 86 88 00 Order +46 31 86 88 20 , Technical Support +46 31 86 88 60 7 321820 061495 Fax +46 31 86 88 10,, www.breas.com, Date: 2023-10-17 | 24564...
Page 3: Table Of Contents
Adjusting the Vivo 45 Patient Settings ........
Page 4 Functions and Parameters in the Vivo 45 ........
Page 5 Using the Vivo 45 with the Trolley ........
Page 6 6.1.1 Alarm Indication ............85 6.1.2 Audible Signal Pause .
Page 7 Cleaning the Vivo 45 ........
Page 8 Vivo 45 Essential Performance........
Page 9: Introduction
CPAP (Continuous Positive Airway Pressure) Compatible Patient Circuits The Vivo 45 should be used with a leakage circuit and a suitable patient interface or an MPV circuit. See 9 Accessories and Parts, page 139 for detailed information about compatible patient circuits.
Page 10: Intended Use
For non-invasive use it may be a mask, mouthpiece or pillow interface. See the patient inter- face’s instructions for use when selecting the interface to use. Data Log The Vivo 45 has an internal memory with a data log that holds the following data: • Running hours •...
Page 11: Adverse Effects
Day-to-day caregivers, patients, relatives and other non-professional users may operate the Vivo 45 with the Home mode activated, after it has been set up according to the prescribed treatment. In Home mode, some settings and controls are locked or hidden.
Page 12: About This Manual
Training The lay operator shall be trained to basic knowledge of the Vivo 45 and in the specific oper- ations they are assigned to perform. The training shall be based on this user manual and the responsible clinical personnel shall assess the level of training required for each lay operator.
Page 13: Manufacturer Information
Phone +46 31 868800, Order: +46 31 868820, Technical support: +46 31 868860 +46 31 868810 UK Sales and Support Information UK Responsible Person: Breas Medical Ltd Phone UK Head Office +44 (0)1789293460 Fax UK Head Office +44 (0)1789262470 General Enquiries and Ordering orders@nippyventilator.com...
Page 14: Safety Information
Every other use may lead to risk of personal injury! Risk of Insufficient Ventilation Usage outside the specified operating conditions may cause reduced performance. The Vivo 45 must only be used in accordance with the operating conditions specified in this manual. Risk of Reduced Safety and Performance Accessories that have not been verified to be compatible with the Vivo 45 might affect safety features and performance negatively.
Page 15 Risk of Unnoticed Critical Conditions • All the physiological alarms of the Vivo 45 must be set at safe levels that will effec- tively warn the user of any risk. The alarm levels should be assessed considering the patient’s treatment settings.
Page 16: Electrical Safety
If you suspect that the device has been mistreated, perform a functional check before taking it to use. A basic functional check can be performed as described in 4.5 Inspecting the Vivo 45 before Use , page 35. A complete functional check can be performed by an authorized service technician.
Page 17: Environmental Conditions
Caution should be exercised if the room temperature is greater that 36°C (97°F). Risk of Faulty Treatment If a room humidifier is used, place it at least 2 meters away from the Vivo 45. Risk of faulty Treatment The performance of the Vivo 45 may deteriorate at altitudes or ambient temperatures outside the operation conditions specified in the chapter Technical Specifications.
Page 18: Usage Of Patient Circuit
Do not use or store the Vivo 45 in a magnetic resonance (MR) environment. Use of the Vivo 45 in an MR environment may result in malfunction of the Vivo 45 and pose unacceptable risk to the patient, medical staff or other persons.
Page 19 WARNING! Risk of Cross-Contamination Patient circuits might get contaminated by exhaled gases. To avoid cross-contamination, always use a properly cleaned or a new patient circuit when the Vivo 45 is to be used by a new patient. NOTE For masks and accessories, always follow the manufacturer’s instructions.
Page 20: Usage Of Filters
Replace or clean the air inlet filters as specified in the Maintenance chapter. Using old or clogged filters may cause the Vivo 45 to operate at higher temperatures than intended. When operating the Vivo 45, make sure that the air inlet and filters are not obstructed or occluded. Risk of Insufficient Ventilation Insufficient ventilation may cause transient hypoxia.
Page 21: Cleaning And Maintenance
The Vivo 45 should be regularly cleaned and maintained in accordance with this operat- ing manual. WARNING! Risk of Faulty Treatment Service and Maintenance of the Vivo 45 shall not be performed when the Vivo 45 is in use. WARNING! Risk of Electric Shock High voltage contact may cause cardiac arrhythmia.
Page 22: Usage Of Oxygen
The presence of oxygen can speed up combustion of inflammable materials. Risk of Fire When oxygen is used with the Vivo 45, the oxygen flow must be turned off when the Vivo 45 is not operating. Oxygen delivered into the patient tubing may accumulate within the machine enclosure.
Page 23 CAUTION! Supplemental oxygen is added before the volume measurement sensor and thereby included in the measurements. However, the oxygen concentration still has influence on the volume measurement of the delivered air. This measurement is based on a normal oxygen concentration of 21%. If the oxygen concentration is higher, the actual inspired volume will deviate from the monitored vol- ume as follows: •...
Page 24: Product Description
This section describes the components of the Vivo 45 medical electric equipment. NOTE • There might be local variations of the main components configuration. • The standard Vivo 45 and its packaging do not contain any natural rubber latex. Carry bag Function: Storage for transportation Part No: 006014 Manual...
Page 25: Power Supply
Function: Deliver power to the ventilator Part No: 006396 Power cord Function: Deliver power to the AC power supply Part No: GB: 003521 CN: 005304 EU: 003520 JP: 004834 US: 003522 Vivo 45 Main Unit Main Unit Product Description User Manual Doc. 006149 F-1...
Page 26: Front View
Front View Item Function Sensor Ambient light sensor 2, 3 Alarm (red & yellow) LEDs Alarm indication: Red = High priority Yellow = Medium priority Audio pause LED Paused alarm sound indication Navigation /Setting buttons Navigate on the display /Define settings Mains LED Power source indication: Mains...
Page 27: Side Views
Side Views Click-in compartment side Item Function Audio pause Pause the alarm sound Start/Stop Start/Stop ventilation treatment Patient air outlet Connection for patient circuit Air bypass unit Click-in airway/silencer for use without the click-in humidifier. (If the click-in humidifier is used, it replaces the air bypass unit) Click-in compartment Compartment for either of...
Page 28: Detaching And Reattaching The Side Panels
Filter Side Item Function Cover Side panel Memory card slot (SD card) Memory download Alarm beeper Alarm Sounds Output Patient air inlet Air bypass unit in, replaceable filters Internal battery Compartment for the internal battery sensor hatch Compartment for the optional sensor 3.3.1 Detaching and Reattaching the Side Panels...
Page 29 Reattaching the Filter Side Panel Lift the handle to access the release button (A). 2 To mount the filter side panel, insert the tabs (B) on the lower side of the panel into the holes (C). 3 Press the side panel into the casing until it clicks in place at the button (D).
Page 30: Equipment Designation
Equipment Designation 7 8 9 Description Colour Item/Symbol Electrical connector, for power to the heated patient circuit. Connection for low pressure/ bleed-in oxygen source interface port interface port Remote start/stop, Audio pause, and effort belt interface port Remote alarm and Nurse call inter- face port Network connection port USB data connection port...
Page 31: Additional Symbols
3.4.1 Additional Symbols This section describes symbols and markings that might appear on the parts or packaging of the Vivo 45. Symbol Description Internal battery Product number Read user instructions. Attention: Read the intended use in the manual. Read the Safety chapter in the manual.
Page 32 Symbol Description Meets all requirements for CE marking according to relevant European health, safety and environmental protection legislation Meets all requirements for UKCA marking according to applicable United Kingdom health, safety and environmental protection legislation. Do not obstruct air inlets or outlet. Single patient multiple use.
Page 33: Preparing The Vivo 45 For Use
2 Ensure that the equipment is in good condition. 3 If stored more than 1 month, connect the Vivo 45 to the power supply to recharge the internal battery. 4 Check that the grey and white air filters are installed.
Page 34 Place the Vivo 45 on a solid, flat, and clean surface. The Vivo 45 should be placed lower than the patient in order to prevent the device from falling on the patient, as well as preventing condensed water from reaching the patient.
Page 35: Connecting The Vivo 45 To Mains
CAUTION! • Do not place the Vivo 45 on a soft surface that will prevent the air flow under- neath the device. Never cover the device. • Always position the Vivo 45 so the power supply lays on a surface without strain to the power cord.
Page 36: Connecting The Patient Circuit
3 Connect the power supply’s power cord to the mains supply. To isolate the Vivo 45 from the mains supply, disconnect the power supply. Connecting the Patient Circuit WARNING! Read 2.4 Usage of Patient Circuit, page 16 carefully to make sure all conditions are consid- ered and met.
Page 37: Inspecting The Vivo 45 Before Use
Check that the cables are properly connected. Inspection of Placement • The Vivo 45 shall be placed on solid flat surface below the patient level (see 4.2 Placing the Vivo 45, page 31). • Make sure that nothing can block the air inlet at the side.
Page 38: Adjusting The Vivo 45 Patient Settings
Adjusting the Vivo 45 Patient Settings WARNING! The configuration of the Vivo 45 therapy settings must always be prescribed by a licensed physician and carried out by an authorised health care professional. For detailed information about the treatment parameters of the Vivo 45, see 5.5 Functions and Parameters in the Vivo 45, page 56.
Page 39: Actions At Pre-Use Test Failure
NOTE If the pre-use test has not been performed, the Vivo 45 will operate with default patient circuit compensation. Starting the Pre-use Test Manually On the Others menu, Select Pre-use Test and then Start Pre-use Test. 2 Follow the instructions on the display.
Page 40 The ventilator will apply the default values to compensate for circuit resistance and compli- ance. These values will deviate from the values for the circuit in use. Ensure that the delivered ventilation is closely monitored. Preparing the Vivo 45 for Use User Manual Doc. 006149 F-1...
Page 41: Switch The Vivo 45 On And Off
⇒The Vivo 45 now starts up and enters standby mode. 3 Select Yes/No when asked to “Perform Pre-use Test”. (The Vivo 45 may be configured to not ask for pre-use test at start up. See 5.2.9 The Others Section , page 49.
Page 42 2 Select Stop Ramp using the Up and Down arrow buttons and then stop the ramp by pressing the Right Arrow button. 3 Confirm to stop the ramp. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 43: Using The Menu
The same navigation button can also be used to view additional information in some sections, or it can be designated a temporary function while an event window is active. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 44: Symbols Used In The Menu
Use the left and right buttons to alter parameters, or enter and exit sub sections. 5.2.2 Symbols Used in the Menu Internal battery. For detailed information about charge level indications, see 5.6.4 Battery Icons , page 65. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 45 Circuit with mouthpiece interface shall be used. SpO2 sensor connected connected EtCO connected PtcCO connected Effort belt connected Connection failures are indicated by red coloured belts. Multiple pages High priority alarm event in history list How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 46: Menu Overview
Medium priority alarm event in history list Size and colour of symbols may vary depending on displayed view. 5.2.3 Menu Overview In Home Mode, the Vivo 45 menu has the following section layout: Main Icon explanation Guided setup Setup Setup 1-2...
Page 47: Display Overview
The red lines represent the low and high pressure alarms, the low and high tidal volume alarms. 3. Icons/Alarm Message Information icons are presented here to give a quick overview of the Vivo 45 basic sta- tus (see 5.2.2 Symbols Used in the Menu, page 42). 4. Monitoring Field This field is designed to give a brief overview of the key monitor values.
Page 48: The Main Display, Home Mode
42 for information about each icon. 6. Bar graph representing the tidal volume 7. PEEP value 8. Bar graph representing the current pressure 9. Red lines in the bar graphs represent alarm limits How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 49: The Setup Section, Home Mode
3 Press the Right or Left arrow to select a profile. The treatment settings for the profile are displayed below the profile selection. 4 Confirm the change of Profile by pressing the Yes button. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 50: The Alarm Section
The Alarms section contains 3 pages: The two first are for viewing alarm settings and the third is for viewing the alarm and message history. Shift between the pages by pressing the Alarm button. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 51: The Monitor Section
The monitoring page contains bar graphs for pressure and volume, and a field with meas- urement readings for the monitored values that are applicable for the treatment mode. See 5.3 Monitored Values in the Vivo 45, page 50 for a description on the monitored values. 5.2.9 The Others Section 5.2.9.1...
Page 52: Time And Date
Battery Health (%) • Serial Number Monitored Values in the Vivo 45 Values monitored by the Vivo 45 stored in the data log and displayed on the screen: 1. The monitoring screen: How to Use the Vivo 45 User Manual...
Page 53: Ppeak
Pmean displays the calculated mean value of pressure during a complete ventilatory cycle (inspiratory + expiratory phase). 5.3.4 Leakage Leakage displays the total leakage (intentional and unintentional) as calculated at expiratory pressure level How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 54: Mve
The Spont Rate displays the actual spontaneous breath rate. 5.3.13 % Spont % Spont displays the percentage of spontaneous breaths calculated since the ventilator was last started (not calculated until 100 breaths are registered). How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 55: Spo 2 (Oxygen Saturation)
PtcCO2 cable accessory. Modes in the Vivo 45 In the Modes section of the Vivo 45 display, the operator selects the ventilation mode, breath mode, patient mode and device mode for the treatment. How to Use the Vivo 45 User Manual Doc.
Page 56: Standby And Operating Mode
5.4.1 Standby and Operating Mode Standby mode is defined as the state of the Vivo 45 when it is powered on but without hav- ing treatment or pre-use test started. Operating mode is defined as the state of the Vivo 45 when the blower is operating and pro- ducing an air flow.
Page 57: Pressure Support Ventilation (Psv)
5.4.4.3 Pressure Controlled Ventilation (PCV) In the PCV mode the ventilation is controlled by the Vivo 45. This is done at the preset pressure, breath rate, inspiratory time, and rise time settings set by the operator. The inspiration stops and an expiration starts in two cases: •...
Page 58: Functions And Parameters In The Vivo 45
5.4.4.8 CPAP – Continuous Positive Airway Pressure In CPAP mode the Vivo 45 is applying a continuous positive pressure to the airways. The flow will automatically be adjusted to maintain the set CPAP level. Functions and Parameters in the Vivo 45 The parameters used for controlling the breathing by the Vivo 45 are described below.
Page 59: Parameters' Availability In Different Modes
Depending on the setup for Home mode adjustment, parameters may not be available or have limited ranges when the Vivo 45 is in Home mode. 5.5.1 Parameters’ Availability in Different Modes This table offers an overview of the available parameters in each mode.
Page 60 How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 61: Insp. Pressure
(A)= Adult mode, (P)= Paediatric mode 5.5.6 Insp. Time (Inspiratory Time) The Inspiratory Time setting defines the length of each inspiration from start of inspiration to cycling off to expiration. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 62: Backup Insp. Time (Backup Inspiratory Time)
(2)= Off turns off the assisted breath function (Control mode only). 5.5.10 Exp. Trigger (Expiratory Trigger) The Expiratory Trigger setting defines the moment when the ventilator will cycle from the inspiratory to the expiratory phase. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 63: Max Insp. Time (Maximum Inspiratory Time)
Inspiratory Pressure between two adjustable pressure limits: Min Pressure and Max Pressure. When Target Volume is active, the mode field on the ventilator display will indicate "(TgV)". Unit Default 2000 (A)= Adult mode, (P)= Paediatric mode How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 64: Cpap
Current Insp. Pressure - 2 or Current CPAP 5.5.17 Always Start Ramp The Always Start Ramp determines whether the ramp is started automatically at the begin- ning of the treatment. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 65: Humidifier
When a power source fails, the ventilator will switch to either the external DC (if installed), the click-in battery (if attached) or the internal battery and show a message in the display window. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 66: Power Switchover Tests
5.6.3 Charging the Batteries CAUTION! Do not charge the Vivo 45 while placed in the carry bag or other types of closed or non- ventilated spaces. The internal and click-in batteries are automatically charged when connecting the ventilator to the mains supply. To ensure that the batteries are fully charged, a maintaining charging...
Page 67: Charging Times
Information box displaying state of charge (alters with battery symbol above, when in standby mode) Information box displaying estimated remaining treatment time (alters with battery symbol above, when in treatment mode) How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 68: Internal Battery
When removing the battery, press down the latch at the bottom of the battery compart- ment and tilt the ventilator sideways. Make sure to close the side panel after removing the click-in battery. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 69: Battery Operating Time (Internal And Click-In)
Storing the Internal Battery and the Click-in Battery Storage longer than 1 month should be initiated with half-charged batteries in order to main- tain maximum capacity. Optimal storage temperature is 5 to 30°C (41 to 86°F). How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 70: External Dc
5.6.9 External DC WARNING! Do not connect the Vivo 45 to a wheelchair unless the operating manual for the wheel- chair permits this as this can affect the Vivo 45 performance and consequently result in patient death. The ventilator can be operated from: •...
Page 71: Using Accessories
Connect the nurse call cable at the back of the ventilator. 2 Test the connection by triggering an alarm on the ventilator and verify that the nurse call system activates. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 72: Using The Ventilator With The Fio
TX10 screwdriver. 3 Insert the FiO sensor with the electrical contact side in. 4 Reinstall the hatch. 5 Calibrate the FiO sensor in the advanced settings of the main menu. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 73: Using The Ventilator With The Remote Alarm
5.7.5 Using the ventilator with the EtCO Sensor The EtCO sensor can be connected to the patient breathing circuit and to a Vivo 45 in order to monitor and store CO measurements. The CO measurements will be stored in the ventilator data memory which can be downloaded to a PC and viewed in the ventilator PC software.
Page 74 Incorrect CO zeroing will result in false gas readings. Replace the airway adapter if rain-out/condensation occurs inside the airway adapter. Only use airway adapters distributed by Breas Medical. Do not apply tension to the CO sensor cable. To keep secretions and moisture from pooling on the windows, always position the CO sensor in a vertical position with the green LED pointing upwards.
Page 75 It will click into place when properly sealed. 3 Perform a CO zeroing procedure. 4 Connect the airway adapter to the patient circuit. 5 Make sure to position the CO sensor with the LED pointing upwards. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 76: Maintenance
(< 70%). Disposal The CO sensor must be disposed of in accordance with the local environmental regula- tions regarding the disposal of used equipment and waste. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 77: Using The Ventilator With The Ptcco
Include real time wave forms from the effort belts on the Effort monitoring page. • Store the effort belt measurements in the internal memory. The effort belt measure- ments will also be included in the data that can be downloaded and analysed with Breas PC software. •...
Page 78: Connecting The Effort Belt
Using the ventilator with the Remote Start/Stop NOTE The effort belt communication box and the Remote Start/Stop use the same port on the ventilator. Only one of the accessories can be connected at a time. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 79: Using The Ventilator With The Protective Cover
4. Port for cables and O inlet 5. Mounting straps 6. Patient air inlet CAUTION! Do not cover the air inlets or outlets. 5.7.11 Using the Vivo 45 with the Trolley Intended Use How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 80: Using The Click-In Humidifier
The trolley shall only be used in indoor, hospital environment. The trolley system consists of a trolley base and a mounting bracket. This section describes how to use the Vivo 45 and a trolley with mounting bracket. Mount and dismount the Vivo 45 as shown in the picture: The bottom plate is mounted to the trolley using two screws.
Page 81 The click-in humidifier is intended to humidify the patient air. It is intended for non-invasive use only. The click-in water chamber is for single patient use only. Reusing a water chamber for a new patient might cause a risk of cross-contamination. The Vivo 45 shall not be moved with a filled water chamber installed.
Page 82 If the ventilator is equipped with click-in battery, remove it before installing the water chamber. Follow the instructions in the illustration below to install the water chamber to the ventilator How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 83 The click-in humidifier only operates during treatment. When the ventilator is in standby mode, the humidification is paused. Prerequisites • The water chamber shall be filled with water and attached. • The ventilator shall be connected to the mains power supply How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 84 Always stop treatment before detaching or attaching the water chamber. Make sure the Vivo 45 with the attached water chamber is placed lower than the patient and on a flat surface. This is to prevent personal injury from accidental spillage or from excess water or condensation flowing down the patient tube and into the patient’s...
Page 85: Cleaning The Water Chamber
15 minutes Steranios 2% solution 10 minutes 5.7.13 Using the Patient Circuit with Heated Wire The ventilator may be used with the accessory Patient Circuit, Heated Wire with Cable Connector. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 86 2 Select Heated Circuit Temp and set the temperature according to the respiratory therapist’s prescription. 3 Select Circuit Heating and set it to On. The circuit heating is now activated and will start to operate when the treatment starts. How to Use the Vivo 45 User Manual Doc. 006149 F-1...
Page 87: Alarms
Never leave a patient unattended during an alarm condition. Setting alarm limits to extreme values could put the patient at risk. Permitted distributed alarm systems are Vivo 45 remote alarm with cable and Vivo 45 nurse call cables provided by Breas Medical only.
Page 88: Audible Signal Pause
Audible signals • High priority: 3 signals followed by 2 more. The signal sequence is repeated with a 0.5 second pause and thereafter a 3 second pause. • Function failure: Same signal as the high priority alarm or a constant signal, depend- ing on the kind of function failure.
Page 89: Alarm Reset
6.1.4 Alarm Reset An alarm will automatically be reset once the cause of the alarm has been corrected. In the alarm descriptions, read the Possible cause information and perform corrective actions, if applicable. WARNING! If an alarm condition cannot be corrected, discontinue use and refer the ventilator for service.
Page 90: High Pressure Alarm
A full breath is performed with maximum pressure below the alarm limit. Ventilator action The Vivo 45 will continue treatment according to the current settings. The actual breath is however terminated if the High Pressure alarm limit is reached. Setting range •...
Page 91: Low Pressure Alarm
Alarm text Priority High Alarm condition A Low Pressure alarm will be given when the Vivo 45 pressure fails to reach the low pressure alarm limit for 15 seconds. The low pressure alarm is disabled during ramp periods. Possible cause •...
Page 92: High Peep Alarm
Changes in airway resistance and or compliance. Reset criteria PEEP has gone below the alarm limit (lower than 30% above the set value). Ventilator action The Vivo 45 will continue treatment according to the current settings. Setting range • •...
Page 93: High Vt I (High Inspired Tidal Volume Alarm)
6.3.5 High Vt (High Inspired Tidal Volume Alarm) Property Description High Vti Alarm text Priority Medium Alarm Condition A High Inspired Tidal Volume alarm will be given when the monitored Inspired Tidal Volume exceeds the set limit for the High Inspired Tidal Volume alarm for 15 seconds. Possible cause •...
Page 94: High Mv
6.3.7 High MV Alarm (High Inspired Minute Volume Alarm) Property Description High MVi Alarm text Priority Medium Alarm condition A High Inspired Minute Volume alarm will be given when the monitored inspired minute volume exceeds the set limit for 15 seconds. Possible cause •...
Page 95: High Vt
6.3.9 High Vt Alarm (High Expired Tidal Volume) Property Description High Vte Alarm text Priority Medium Alarm condition A High Expired Tidal Volume alarm will be given when the monitored Expired Tidal Volume exceeds the alarm limit for 15 seconds. Possible cause •...
Page 96: High Mv E (High Expired Minute Volume Alarm)
6.3.11 High MV (High Expired Minute Volume Alarm) Item Description High MVe Alarm text Priority Medium Alarm condition A High Expired Minute Volume alarm will be given when the monitored expired minute volume exceeds the alarm limit for 15 seconds. Possible cause •...
Page 97: High Breath Rate Alarm
Too sensitive setting of the inspiratory trigger setting. Reset criteria The breath rate goes below the alarm limit. Ventilator action The Vivo 45 will continue treatment according to the current settings. Setting range • 10 bpm to 70 bpm (Adult mode) •...
Page 98: Low Breath Rate Alarm
Decrease in the patient’s spontaneous breathing. • Circuit disconnection. Reset criteria The breath rate goes above the alarm limit. Ventilator action The Vivo 45 will continue treatment according to the current settings. Setting range • 4 bpm to 30 bpm (Adult mode, non-MPV modes) •...
Page 99: Apnea Alarm
• Inspiratory Trigger is set too high. Reset criteria Inspiratory effort detected by the Vivo 45. Ventilator action The Vivo 45 will continue treatment according to the current settings. Setting range • 5 to 60 s. (Non MPV mode) •...
Page 100: Rebreathing Alarm
The patient has removed the mask. • Circuit disconnection. • Pilot pressure tube disconnection Reset criteria The leakage is back within limits. Ventilator action The Vivo 45 will continue treatment according to the current settings Setting range • • 6.3.17 Rebreathing Alarm Property...
Page 101: Obstruction Alarm
6.3.18 Obstruction Alarm Property Description Obstruction Alarm text Priority High Alarm condition An Obstruction alarm will be given if the inspiratory breathing tube becomes blocked and remains blocked for 2 consecutive breaths. Ventilator action With each breath cycle, upon detection of an obstruction the ventilator will reduce the airway pressure to the set PEEP.
Page 102: Low Fio
Possible cause Too high flow of bleed-in oxygen. Reset criteria The SpO value goes back below the alarm limit. Ventilator action The Vivo 45 will continue treatment according to the current settings. Setting range • 90 % to 100 % •...
Page 103: Low Spo
6.3.22 Low SpO Alarm Property Description Alarm text Low SpO2 Priority High Definition A Low SpO alarm will be given when the measured SpO below the alarm limit for 30 seconds. Possible cause • Too low flow of bleed-in oxygen. •...
Page 104: Low Etco
6.3.24 Low EtCO Alarm Property Description Alarm text Low EtCO2 Priority Medium Alarm condition A Low EtCO alarm will be given when the measured EtCO below the alarm limit for 30 seconds. Possible cause • Alarm limit is set too high. •...
Page 105: High Pulse Rate Alarm
Bad positioning of the finger probe. Reset criteria The pulse rate goes back below the alarm limit. Ventilator action The Vivo 45 will continue treatment according to the current settings. Setting range 30 to 230 bpm (beats per minute) Setting resolution...
Page 106: Ptcco
Reset criteria External power supply connected to ventilator. Ventilator action The Vivo 45 stops the treatment, and gives the Power Fail alarm for at least 2 minutes. If power is restored within the alarm time, the ventilator will automatically resume treatment with current settings.
Page 107: High Patient Air Temp. (High Patient Air Temperature)
This alarm will be given when the last battery source (internal battery) has 15 minutes of operating time left with current settings. Ventilator action The Vivo 45 will continue treatment according to the current settings. Alarms User Manual Doc. 006149 F-1...
Page 108: Crit. Low Last Power Source Alarm
6.4.5 Crit. Low Last Power Source Alarm Property Description Alarm text Crit. Low Last Power Source Alarm condition A Crit. Low Last Power Source alarm will be given when the last battery source (internal battery or click-in battery) has 5 minutes of operating time left with current settings. Priority High Ventilator action...
Page 109: Spo 2 Signal Lost Alarm
6.4.8 Signal Lost Alarm Property Description Alarm text SPO2 Signal Lost Alarm condition signal lost. Priority High Possible cause Signal lost reported by SpO electronics (due to patient remov- ing the probe from finger, or sensor detached from SpO electronics. Ventilator action The ventilator will continue treatment with the same settings.
Page 110: Co 2 Accuracy Error Alarm
6.4.11 Accuracy Error Alarm Property Description Alarm text CO2 Accuracy Error Alarm condition A CO Accuracy Error alarm will be given when an accuracy error in the CO measurement has occurred. Priority High Ventilator action The ventilator will continue treatment with the same settings. Reset OK message from sensor or sensor disconnected by user.
Page 111: Fio2 Disconnected
Ventilator action The Vivo 45 will continue treatment according to the current settings. Normal atmospheric pressure at sea level will be used as approximation for the temporary ambient pressure compensa- tion.
Page 112: Temperature Comp. Lost
6.4.16 Temperature Comp. Lost (Ambient Temperature Compensation Lost Alarm) Property Description Alarm text Temperature Comp. Lost Alarm condition An Ambient Temperature Compensation Lost alarm will be given when the automatic ambient temperature compensation is out of order. There is no communication with the air temperature sensor or the value is out of range (less than -30°C (-22°F) or more than 70°C (158°F).
Page 113: Low Alarm Battery Alarm
6.4.19 Low Alarm Battery Alarm Property Description Low Alarm Battery Alarm text Alarm condition An alarm for Low Alarm Battery will be given if the alarm battery is not charged enough to have power for a Power Fail alarm for at least 2 minutes.
Page 114: Heated Circuit Temp. Alarm
6.4.22 Heated Circuit Temp. Alarm Property Description Alarm text Heated Circuit Temp. Alarm condition A Heated Circuit temp alarm will be given when the measured temperature of the heated wire is outside the tolerance. Priority Medium Ventilator action The ventilator will continue treatment with the same settings. Priority Medium Reset...
Page 115: Humidifier Fault Alarm
6.4.24 Humidifier Fault Alarm Property Description Humidifier Fault Alarm text Alarm condition • All humidifier enabling conditions have been satisfied for 10 minutes, and • No humidifier setting changes have been made for 10 minutes, and • Heater plate temperature < 50°C (122 °F) •...
Page 116: Internal Function Failure
The ventilator will stop the treatment and shut down. Action to take Restart the Vivo 45. If the alarm persists or reoccurs: Take a note of the error code and contact your supplier of the Vivo 45 . 6.4.27 Air Temp. Sensor Fail Alarm Property...
Page 117: Database Integrity Fail Alarm
6.4.29 Database Integrity Fail Alarm Property Description Database Integrity Failed Alarm text Priority High Alarm Condition This alarm is given when the database integrity check fails. Ventilator action The ventilator will continue treatment with the same settings. Reset action Rebuild the database and restart the ventilator. 6.4.30 Cooling Fan Error Alarm Property...
Page 118: Internal Temp High Alarm
The audio pause LED lights yellow. • In about a second, both LEDs are turned off. If the test fails, do not use the Vivo 45. Contact your supplier of the Vivo 45 for a technical check. 6.5.2 Mandatory Alarm Tests This alarm test should be performed every 24th month or if the ventilator’s function needs...
Page 119 Alarm Test Preparation Connect the ventilator patient circuit to a test lung. 2 Connect the ventilator to Mains power supply. 3 Start the ventilator. 4 Adjust the settings as follows: Setting Value Ventilation Mode Pressure Support Ventilation (PSV) Patient Mode Adult Insp.
Page 120: Optional Alarm Tests
Related Alarm Test This alarm test applies if the EtCO accessory is used. Connect the EtCO sensor with an attached airway adapter to the Vivo 45. 2 Disconnect the airway adapter from the CO sensor. ⇒ The check CO adapter alarm shall be given.
Page 121 6.5.3.1 High PEEP Alarm Connect the ventilator patient circuit to a test lung and a CPAP device. Set the CPAP device treatment pressure to 10 cmH 3 Adjust the ventilator settings as follows: Setting Value Ventilation Mode Insp. Pressure 15 cmH PEEP 5 cmH Breath Rate...
Page 122: Cleaning And Maintenance
2 Remove the patient circuit. 3 Disconnect all electric cables. 4 Clean the outside of the Vivo 45 using a lint-free cloth with a mild soap solution, and/or ethanol 70% for surface disinfection. 5 If the click-in humidifier is used, clean it as described in 5.7.12.6 Cleaning the Water Chamber, page 83.
Page 123: Air Pathway Disinfection
• Air inlet with filters In case of contamination, the internal air pathways of the Vivo 45 may be disinfected up to 5 times by a maximum 60 minute long validated ozone gas process. Low resistance bacteria filter, if used, should be replaced every 24 hours.
Page 124: Cleaning And Replacing The Filters
Cleaning and Replacing the Filters Patient air filters NOTE • Coarse filter (grey): This is a washable filter, wash the filter at least once a week and replace once a year. See 7.2.1 Washing a coarse filter, page 123 for washing instructions.
Page 125: Washing A Coarse Filter
Service and Repair The service and repair of the ventilator must only be carried out by authorised service per- sonnel in accordance with Breas service instructions. Service inspections must always be car- ried out following any repairs to the device.
Page 126 equipment and waste. Contact your service provider for information regarding the disposal procedure. NOTE Batteries used with the ventilator shall be recycled in accordance with the local environ- mental regulations. Cleaning and Maintenance User Manual Doc. 006149 F-1...
Page 127: Technical Specifications
Technical Specifications System Description Leakage Port Configuration This diagram provides an overview of the ventilator system when used with a leakage port patient circuit. 1. Vivo 45 2. Tube 3. Leakage port / Patient interface connection 4. Patient 8.1.1 Pneumatic Diagram for the ventilator...
Page 128: Data
Low pressure/bleed-in oxygen connection Data 8.2.1 Worst Case Accuracy Pressure Control Modes The worst case Vivo 45 configuration is the 15 mm patient circuit with HCH humidifier, bacterial filter and EtCO sensor. 8.2.2 Modes Specifications This section lists the settings that can be made for the ventilator’s modes.
Page 129: Technical Specifications
Technical Specifications User Manual Doc. 006149 F-1...
Page 130 Technical Specifications User Manual Doc. 006149 F-1...
Page 131 Technical Specifications User Manual Doc. 006149 F-1...
Page 132: Monitored Values Specifications
8.2.4 Monitored Values Specifications This section describes the ranges and tolerances for monitored values on the Vivo 45. All stated tolerances include measurement uncertainty. The accuracies have been tested with all allowed configurations. Stated tolerances only disclose the maximum tolerance.
Page 133: Power Supply
Total Rate Range/Performance: 0 to 99 bpm. Tolerance: ±1 bpm Spont Rate Range/Performance: 0 to 99 bpm. Tolerance: ±1 bpm % Spont Range/Performance: 0 to 100%. Range/Performance: 70 to 100%. Tolerance: ±3 digits. No motion and flex sensor. Pulse Rate Range/Performance: 25 to 240 bpm.
Page 134: Other
Maximum limited pressure during single fault condition: 80 cmH2O (PCV, PSV) 30 cmH2O (CPAP) Breathing resistance under single-fault: <6 cmH2O at 30 l/min, <6 cmH2O at 60 l/ Vivo 45 Dimensions W × H × D: 216 × 159 × 152 mm Weight: 2.4 kg...
Page 135: Emission And Immunity Declaration
The performance of all functions of the ventilator is considered as essential performance for the purpose of immunity testing. 8.3.1 Vivo 45 Essential Performance The ventilator will deliver ventilation at the patient-connection port within its published accuracy specifications and within the alarm limits set by the operator, or generate an alarm...
Page 136: Guidance And Manufacturer's Declaration - Electromagnetic
IEC 61000-4-8 in a typical commercial, hospi- tal and residential environment. Voltage dips, short 0% U , 0.5 cycle (multiple Vivo 45 runs on internal bat- interruptions and phase analysis); tery during voltage dips, short 0% U , 1 cycle;...
Page 137 Immunity Test Compliance Level Electromagnetic Environ- ment - Guidance (150 kHz to 80 MHz) Conducted RF IEC d=0.35*√P m at 150 kHz to 61000-4-6 (inside ISM/ASR 80 MHz bands) Radiated RF IEC 10 V/m 80 MHz to 2.5 GHz d= 1.2*√P m at 80 MHz to 61000-4-3 800 MHz d= 2.3*√P m at 800 MHz to...
Page 138: Guidance And Manufacturer's Declaration - Electromagnetic Emission
8.3.3 Guidance and Manufacturer's Declaration – Electromagnetic Emission The ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment. Emissions test Compliance Level Electromagnetic Environ- ment - Guidance...
Page 139: Recommended Separation Distances Between External Power
8.3.5 Recommended separation distances between external power conductors and the ventilator Rated maximum current in Separation distance (m) conductor (A) 50-60 Hz d= I/2πH= I/188 0.005 0.05 0.16 For conductors rated at a maximum current not listed above, the recommended separation distance d in metres (m) can be estimated using the equation d=I/2πH, where I is the maxi- mum current rating of the conductor in amperes (A) according to the transmitter manufac- turer;...
Page 140 Delivery Settings, Alarms High Pressure Alarm: 25 cmH O (Adult) 20 cmH O (Paediatric) Low Pressure Alarm: 10 cmH High PEEP Alarm: Off Low PEEP Alarm: Off High Vt Alarm: 500 ml (Adult), 400 ml (Paediatric) Low Vt Alarm: 300 ml (Adult), 100 ml (Paediatric) High MV Alarm: Off Low MV...
Page 141: Accessories And Parts
IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. The following Breas accessories have been verified for use with the Vivo 45.: Patient Circuits and Air Delivery Accessories...
Page 142 Circuit: Single limb heated wire 15 mm, disposable Function: Deliver heated air to the patient, non- invasively Part No: 006193 Circuit: Single limb 22 mm with leakage port and bacterial filter, disposable Function: Delivers air to the patient (applied part) Part No: 007615 Circuit: 1.8m x 15mm Smoothbore Disposable Function: Deliver air to the patient...
Page 143 VFE (Viral Filtration Efficiency): 99.999 % Part No: 007963 Low pressure oxygen adapter Function: Oxygen tube adapter with connector for the Vivo 45. Part No: 005032 Circuit: Single limb for Mouthpiece ventilation (MPV) Function: Deliver air to the patient Part No: 006093...
Page 144: Power Accessories
MPV arm Function: Hold an MPV circuit so Mouthpiece can be mounted close to the patient Part No: 006095 Power Accessories Car Adapter Cable Function: 12–24 VDC car adapter cable. Part No: 007653 Power Supply Function: Deliver power to the ventilator Part No: 006396 Power cord Function: Deliver power to the AC power supply...
Page 145 XPAC - External battery with charger Function: Extends usage time of supported Breas products. Part No Cable for connection to device: 007671 Part No Charger with cable: Single: Charger with one battery Dual: Charger with two batteries Single: 007995, Dual: 007999...
Page 146: Monitoring Accessories
Monitoring Accessories Breas PC software Function: Data monitoring software Part No: 006718 USB cable Function: Data cable: PC to Vivo 45 (USB to USB) Part No: 005757 Memory card Function: Storage and transfer of settings, patient data and usage data...
Page 147: Remote Start/Stop
Remote alarm cable Function: Part No: 10 m: 006359, 25 m: 006360, 50 m: 006361 Nurse call cable Function: Connect the ventilator to a hospital nurse call system Part No: NO: 006365 NC: 006364 10 kΩ, NO: 006363 10 kΩ, NC: 006362 Remote start/stop Function: Start and stop the ventilator remotely.
Page 148: Spo 2 Module
module Function: Connection interface Part No: 006369 sensor Function: Finger Clip SpO sensor Part No: Adult: 006589 Paediatric: 006590 sensor Function: Multisite SpO sensor Part No: 006591 EtCO sensor Function: Measure CO in the airflow Part No: 006346 Airway adapter Function: Connects the EtCO sensor to the patient circuit...
Page 149 PtcCO Cable, Sentec Function: Connects the ventilator to a Sentec PtcCO monitor. Part No: 006179 PtcCO Cable, Radiometer Function: Connects the ventilator to a Radiometer TCM5 PtcCO monitor. Part No: 008392 Effort belt communication box Function: Connects the ventilator to one or two effort belts.
Page 150: Ventilator Filters And Detachable Parts
Ventilator Filters and Detachable Parts Patient air inlet filter, fine, white, disposable Function: Fine inlet air filtration. Material: AS 100 NaCl Penetration: (0.65 μm NaCl @ 95 l/min) = <7.35% Part No: 007103 (5pcs) Patient air inlet filter, coarse, grey, washable Function: Coarse inlet air filtration Material: Bulpren S 28133 Filter diameter: 1080-1580 Microns...
Page 151: Side Panels
Click-in water chamber Function: Humidify the patient air Part No: 006490 Side panels Function: Protect the internal ventilator components. Part No: Grey: 007065, Blue: 007066, Light blue: 007518 Other Accessories Trolley Function: Mobile use, transportation Part No: 007384 Accessories and Parts User Manual Doc.
Page 152 Patient circuit arm Function: To support a patient circuit. Part No: 007917 Universal rail clamp Function: Attach a humidifier to a trolley. This acces- sory is part of the trolley system. Part No: 007858 Accessories and Parts User Manual Doc. 006149 F-1...
Page 153: Mounting Bracket
E-cylinder holder Function: Attach an E-cylinder to a trolley. This accessory is part of the trolley system. Part No: 005128 IV-pole Function: Pole with hooks to hang IV fluid bags. Part No: 007859 Mounting bracket Function: Mount the ventilator to a stand / trolley / rail system.
Page 154: Protective Cover
Protective cover Function: Shock protection Part No: 006067 Lightweight Mobility Bag Function: Mobile use Part No: 007555 Carry bag Function: Storage for transportation Part No: 006014 Accessories and Parts User Manual Doc. 006149 F-1...
Page 155: Patient Settings
Patient Settings This section can be copied and used for noting the patient’s settings. Patient Settings - Vivo 45 Patient ....................Date ....................Clinic ....................Set by ....................Ventilation mode:................Patient Circuit Insp. Pressure Inspiratory Trigger PEEP Expiratory Trigger Breath Rate...
Page 156: Faa Compliance
Electromagnetic Compatibility (EMC) in accordance with the current version of RTCA/DO-160, Section 21, Category M. Breas Medical has successfully completed testing for the ventilator System. The ventilator System complies with RTCA/DO-160, Section 21, Category M and can be considered FAA compliant.
Page 157: Index
Index High PEEP......90 High pressure ..... . 88 High pulse rate .
Page 158 Assisted Pressure Controlled Accuracy Error Alarm (CO Sen- Ventilation sor Error) alarm ....108 definition ......56 CO2 sensor Assisted Pressure Controlled Ventila- clean .
Page 159 air pathway ......121 Heated circuit Display settings ......49 home mode overview .
Page 160 Reference......10 Warning ......10 Main components.
Page 161 mouthpiece......56 PCV(A) Navigate definition ......56 menu .
Page 162 specification ..... . .126 Specifications Ramp CO2 sensor......126 start .
Page 163 set........49 Time format ......49 Treatment select preset profile .

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